DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM
First Claim
Patent Images
1. A prosthetic valve, comprising:
- a leaflet cyclable between a closed configuration for substantially preventing blood flow through the prosthetic valve and an open configuration allowing blood flow through the prosthetic valve, the leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via the elastomer, the leaflet having a ratio of leaflet thickness (μ
m) to number of layers of fluoropolymer of less than about 5.
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Abstract
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.
23 Citations
32 Claims
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1. A prosthetic valve, comprising:
a leaflet cyclable between a closed configuration for substantially preventing blood flow through the prosthetic valve and an open configuration allowing blood flow through the prosthetic valve, the leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via the elastomer, the leaflet having a ratio of leaflet thickness (μ
m) to number of layers of fluoropolymer of less than about 5.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A prosthetic valve, comprising:
a leaflet comprising a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the at least one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via the elastomer, the composite material comprising less than about 80% fluoropolymer by weight. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A prosthetic valve, comprising:
a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer substantially filling the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight, the more than one layer of composite material being coupled together via the elastomer.
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29. A prosthetic valve, comprising:
a leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via a layer of the elastomer between each of the more than one fluoropolymer layer, the leaflet having a ratio of leaflet thickness (μ
m) to number of fluoropolymer layers of less than about 5.
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30. A prosthetic valve, comprising:
a polymeric leaflet having a thickness of less than about 100 μ
m, wherein the polymeric leaflet is formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via a layer of the elastomer between each of the more than one fluoropolymer layer.
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31. A prosthetic valve, comprising:
a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight, the more than one layer of the composite material being coupled together via a layer of the elastomer between each of the more than one layer of the composite material.
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32. A prosthetic valve, comprising:
a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the at least one fluoropolymer layer, the more than one layer of the composite material being coupled together via a layer of the elastomer between each of the more than one layer of the composite material, each of the more than one layer of the composite material comprising less than about 80% fluoropolymer by weight.
Specification